Internet-delivered CBT for Patients With NCCP (IKSIT)

Linköping University (LiU)

Status: Completed

Conditions: Non-cardiac Chest Pain; Cardiac Anxiety

Treatments: Other: Information program; Behavioral: Internet-delivered cognitive behavioral therapy (I-CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03336112

I-CBT for NCCP

Details and patient eligibility

About

Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out', many patients think they have an undetected cardiac disease (i.e. they suffer cardiac anxiety) as no other explanation is offered. They therefore avoid activities that they believe might be harmful to their heart, leading to greater ill-health, and increased healthcare use and societal costs. Targeting cardiac anxiety with psychological interventions might break this vicious circle and improve patient outcomes. Patients need to evaluate the way they perceive and handle their chest pain, which can be done with cognitive behavioral therapy (CBT).

The aim of this study is therefore to evaluate the short- and long-term effects of an Internet-delivered CBT (I-CBT) program on psychological distress and other patient-reported outcomes in patients with NCCP. A second aim is to explore factors related to implementation of I-CBT in clinical care. The study has a randomized controlled design comparing I-CBT with Internet-delivered information program. Quantitative methods will be used to evaluate the effectiveness of the I-CBT program. Implementation issues will be evaluated from the perspectives of patients, healthcare professionals and policymakers using qualitative methods.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 2 healthcare visits due to NCCP during the last 6 months
• patients suffering from cardiac anxiety (score ≥ 24 on the Cardiac Anxiety Questionnaire-CAQ)

Exclusion criteria

• language difficulties
• not able to perform physical activity/exercise due to physical constraints
• patients with severe depressive symptoms
• patients with acute ischemic heart disease
• patients with no access to computer/tablet and/or Internet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

109 participants in 2 patient groups

Intervention group

Experimental group

Description:

5 weeks guided internet-delivered cognitive behavioral therapy program The program consists of psychoeducation, exposure to physical activity, and awareness (mindfulness) training.

Treatment:

Behavioral: Internet-delivered cognitive behavioral therapy (I-CBT)

Control group

Active Comparator group

Description:

Information program delivered by the Internet during 5 weeks.

Treatment:

Other: Information program